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Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
Cerilliant
Cantor Fitzgerald
UBS
Colorcon
Fuji
Novartis
Chubb
Moodys

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,889,186

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Summary for Patent: 8,889,186
Title:Modified release compositions comprising tacrolimus
Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
Inventor(s): Holm; Per (Vanlose, DK), Norling; Tomas (Lyngby, DK)
Assignee: Veloxis Pharmaceuticals A/S (Horsholm, DE)
Application Number:14/079,466
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form; Formulation;

Drugs Protected by US Patent 8,889,186

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No ➤ Sign Up ➤ Sign Up PROPHYLAXIS OF ORGAN REJECTION ➤ Sign Up
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No ➤ Sign Up ➤ Sign Up PROPHYLAXIS OF ORGAN REJECTION ➤ Sign Up
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up PROPHYLAXIS OF ORGAN REJECTION ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 8,889,186

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,994,214 Solid dispersions comprising tacrolimus ➤ Sign Up
8,591,946 Modified release compositions comprising tacrolimus ➤ Sign Up
9,161,907 Modified release compositions comprising tacrolimus ➤ Sign Up
8,617,599 Modified release compositions comprising tacrolimus ➤ Sign Up
8,623,411 Modified release compositions comprising tacrolimus ➤ Sign Up
9,757,362 Modified release compositions comprising tacrolimus ➤ Sign Up
8,889,185 Modified release compositions comprising tacrolimus ➤ Sign Up
8,623,410 Modified release compositions comprising tacrolimus ➤ Sign Up
8,486,993 Solid dispersions comprising tacrolimus ➤ Sign Up
8,586,084 Modified release compositions comprising tacrolimus ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 8,889,186

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
China 101869561 ➤ Sign Up
Germany 602004028023 ➤ Sign Up
Denmark 1663216 ➤ Sign Up
Denmark 1663217 ➤ Sign Up
European Patent Office 1663216 ➤ Sign Up
European Patent Office 1663217 ➤ Sign Up
Spain 2348640 ➤ Sign Up
Spain 2376238 ➤ Sign Up
Hong Kong 1096032 ➤ Sign Up
Japan 2007504103 ➤ Sign Up
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Chinese Patent Office
McKesson
Dow
Julphar
Cerilliant
Citi
Fish and Richardson

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